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RATIONAL DRUG USE

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SULTANATE OF OMAN

MINISTRY OF HEALTH

THE DIRECTORATE GENERAL OF P HARMACEUTICAL AFFAIRS

AND DRUG CONTROL









RATIONAL DRUG USE









MAY 2000









1

National Plan to Promote Rational Drug Use





Introduction

Any National Drug Policy should be concerned not only, with the supply of safe, effective

and appropriate drugs for the country but also in the way that they are prescribed and

dispensed by health personnel. This later aspect is often neglected as it is more difficult to

address. However the impact of irrational prescribing and poor dispensing is increased

morbidity and mortality, a waste of resources, unwanted side effects and adverse psycho-

social reactions.

There are many factors that influence prescribing patterns, not least of which are patient

demands and misbeliefs. Thus the education of the patient and provision of basic health

information to the public is an integral part of any Rational Drug Use Program.

Interventions to improve prescribing and dispensing practices can be educational, managerial

and regulatory. Their effect must be evaluated and this involves making an accurate

assessment or audit of the current situation by using, for example, prescribing and dispensing

indicators, knowledge, attitudes and practice (KAP) studies etc. and then repeating these

evaluations after the interventions have been implemented.

Any program to promote Rational Drug Use requires manpower and resources which may

initially involve some financial outlay. However there may be considerable potential saving in

the long term, both in respect to the total drug budget and also to the health of the Nation.

The Government is concerned at the escalating increase in the drug budget. It is hoped that

this 5 year National Plan will have the effect of improving and rationalizing overall

prescribing habits to make them more cost effective.







1. An Overview

1.1 Introduction









2

Most doctors and pharmacists are expatriates trained in varying countries and institutions.

Inevitably prescribing and dispensing habits vary. The studies which have been carried out

identify several undesirable trends:-

• polypharmacy (multiple drug prescribing)

• patient driven prescribing

• over prescribing of antibiotics

• lack of specific standard treatment protocols leading to inconsistent prescribing resulting in

the use of expensive drugs where less expensive drugs may be adequate

• inadequate drug information given to patients by the health care providers. This may be

due to pressure of work or to language difficulties.

1.2 Proposed Base Line Survey of Prescribing and Dispensing Indicators

It is essential that initially an overall assessment be made to determine the extent of the

prescribing and dispensing problems. The Directorate General of Pharmaceutical Affairs and

Drug Control (DGPA&DC), with the help of the Hospital Drug and Therapeutic Committees,

students from the Medical School and the Assistant Pharmacy Institute, will carry out a base

line surveys of prescribing and dispensing indicators in randomly selected Hospitals and

Health Centres. These will follow the procedure laid down in the WHO publication “How to

Investigate Drug Use in Health Facilities”. These surveys will be coordinated by the tutors of

the training institutes and the Rational Drugs Use Team and will be ongoing. They will form

part of the teaching programs of the Rational Use of Drugs. The results of the surveys will be

circulated to all health facilities with comments from the DGPA&PA.

A follow up surveys will be carried out at regular intervals after suitable interventions have

been put in place.

Those hospitals and health centres not included in this survey will be encouraged to carry out

their own survey using the same indicators to identify excessive prescribing or bad dispensing

practices. Pharmacy Assistant students attached to these institutions will be involved in these.

1.3 Proposed Knowledge, Attitude and Practice (KAP) Studies of Drug Use by the

Public









3

A limited survey will be carried out to assess the knowledge, attitudes and practices of

selected patients attending hospital outpatients and health centres regarding their perception

of illness and their knowledge, attitudes and practice towards the use of drugs. A suitable

questionnaire will be developed after consultation with WHO. The answers obtained will be

analyzed by the Rational Drug Use Team and presented to the DGPA&DC.

1.4 ABC Analysis of Drug Expenditure

ABC analyses of drug expenditure will continue to be performed on a national and regional

basis to facilitate the early detection of significant variations and excessive use.

1.5 Proposed Review of Inservice Training

Each regional hospital will be sent a questionnaire on which they will be asked to give details

of what inservice training they provide at the present and what is planned for the future. (see

4.2.1).







2. Manpower Development.

2.1 Rational Drug Use Team

2.1.1 It is proposed that posts be established for a Rational Drug Use Team being:-

• A full time Medical Practitioner with an interest in therapeutics. His or her terms of service

are outlined in Appendix 1.

• A full time Clinical Pharmacist with experience in communication and patient education.

His or her terms of service are outlined in Appendix 2.

These two officers will be able to call on the services of experts from the Ministry of Health

as and when required. The two full time officers will be part of the DGPA&DC..

2.1.2 The two full time Rational Drug Use Officers will be provided with office space,

computers and such communication facilities as may be felt appropriate. They may initially

need some periodic input from external expatriate sources such as WHO. The Clinical

Pharmacist dealing with patient education should be bilingual with fluent English and Arabic.

2.1.3 The two full time Rational Drug Use Officers will cooperate with the Directorate

General of Health Affairs in the continuing education of doctors and paramedical staff.

2.2 Central Drug Committee









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2.2.1 The activities of the Central Drug Committee will be unchanged but they should be

actively involved in the approval of:-

• A National Drug Formulary

• Standard Treatment Guidelines

• Treatment Protocols for the Use of Antibiotics (these may be included in the STGs)

• Detaile0d Management Protocols for Specific Conditions e.g. ARI, STDs, Hypertension,

Diabetes etc.

2.3 Hospital Drug and Therapeutics Committees

2.3.1. It will be required that all Government Hospitals or Polyclinics establish and maintain

drug and therapeutic committees in order to ensure the correct, efficient and cost effective

handling and use of drugs.

2.3.2 These committees exist in some referral hospitals at present but may not function well.

Their procedures will be further tightened up by additional guidelines issued from the

DGPA&DC. These will reinforce those already issued.

2.3.3 The membership of these committees are as follows

• Medical Officer in Charge (Chairman)

• Senior Pharmacist (Member and Secretary)

• Heads of Clinical Departments

• Senior Nurse or Matron

2.3.4 In the absence of the above, their nominated representatives or equivalents should

attend. Other members can be added if necessary. The Pharmacist, together with the officer

in charge, will have a pivotal role in the committee.

2.3.4 The Hospital Drug and Therapeutics Committee meetings should:-

• meet at least monthly

• be carefully planned with a predetermined agenda, chairperson (medical

officer in charge), and secretary (chief pharmacist) to record the minutes.

• have a defined length

• submit the minutes and findings for consideration by the concerned

authorities.









5

2.3.5.This committee will monitor individual prescribers drug usage in their establishment and

to identify aberrant prescribing patterns so that the appropriate interventions can be made. It

will also , together with the designated clinical tutor, (2.5.1) initiate and coordinate inservice

training in their establishment.

2.3.6 The duties of the drug and therapeutics committee are outlined in Appendix 3.

2.4 Tutors in Training Institutions

2.4.1. Tutors responsible for the teaching of therapeutics and pharmacology in the Oman

medical school, the Oman Assistant Pharmacy Institute and other health training institutions

will be targeted by the DGPA&DC in cooperation with the Directorate General of Health

Affairs to be sure that they appreciate the importance of Rational Drug Use. The literature

relating to Rational Drug Use will be provided and seminars held.

2.5 Clinical Tutors

2.5.1 The Directorate General of Health Affairs will develop programs of inservice training. A

senior clinician or head of a clinical department will be designated as clinical tutor..

2.5.2 These tutors will be responsible for the organization of inservice training within their

hospital or polyclinic.

2.5.3.These tutors will be targeted with literature and small seminars regarding drug usage and

rational prescribing by the prescriber training officers.

2.5.4 The tutors will, together with the Hospital Drug and Therapeutics Committees, be

responsible for supervising audits of the prescribing and dispensing habits of those doctors,

pharmacists and assistant pharmacists working in their hospital or polyclinic and will

encourage of the rational use of drugs.. They will plan and monitor the success of suitable

interventions to improve the performance and cost effectiveness of health care delivery in

their establishments.

2.6 Pharmacists and Assistant Pharmacists

2.6.1 Further ways should be found to increase the number of staff and up grade their status.

2.6.2 The job descriptions of pharmacists and assistant pharmacists will be reviewed and

clearly defined, particularly in relation to the rest of the health care team. Their right to

question badly written prescriptions and irrational prescribing will be emphasized.









6

2.7. Private Sector Pharmacists

2.7.1 The standard of dispensing and delivery of patient education in the private pharmacies

will continue to be monitored closely. Ways in which they can collaborate with the

government sector will be explored.

2.7.2 Private and Government pharmacists will be invited to those educational activities

which will improve their performance.

2.8 Private Practitioners

2.8.1 Methods will be sought to supervise the prescribing habits of Private Practitioners

through the departments concerned.

2.9 Nurses

2.9.1 In peripheral health centers nurses may have to prescribe in emergency situation. This is

where is only one doctor, that doctor is not available. A list of drugs and the circumstances in

which a nurse can give them to a patient will be drawn up by the central drug committee

Nurses in one doctor health center will be trained to diagnose and treat emergencies

3. Resources

3.1 Educational Materials

3.1.1 Educational material relating to the Rational Use of Drugs will be designed by the

“Rational Drug Use Officers” to assist in preservice and inservice education and sent to

Training Institutes and Health Facilities. This will include the preparation of lecture notes on

topics such as good prescribing and dispensing practices with the relevant overheads and

slides.

3.1.2 Patient information leaflets and health education posters will be designed by the

“Rational Drugs Use Officers” and after suitable approval and field testing circulated to the

relevant health facilities. The focus of this National Awareness Campaign will depend on the

findings of the base line study into the knowledge, attitudes and practice of the public toward

the proper use of drugs (1.2).

3.2 Computerization









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3.2.1. There will be a long term commitment to computerization of all departments involved

with drug supply. This will be expensive and require more staff. It will need to be piloted in

selected health facilities to ascertain its effectiveness. However these computerized stock

control and prescription management systems are in general use in the Europe and have found

to be cost effective. Funds should be made available for this.

3.2.2. Medical Stores and pharmacies in every hospital will be provided with a computer

system capable of carrying out stock control, predictions of future drug use and ABC

analyses

.3.2.3 The computerized pharmacies will be able to monitoring of prescribing habits.

Software will be installed to generate computer labeling of patient drugs with suitable warning

messages.

3.2.4 Out Patient Clinics in the hospitals and Health Centres will be equipped with computers

in the clinics. These computers will be linked on a National basis. This will initially be piloted

in selected health facilities. Software installed will:-

• allow prescribers to issue computer generated prescriptions and repeat

prescriptions.

• put in automatic stop orders. ( the patient will not be able to receive further

medication without seeing a doctor).

• give warning of any adverse drug reactions or individual allergies.

• provide other details of the patient medical and family history, especially

attendances at other clinics or with other departments in the same hospital.

• inform the prescriber of any previously prescribed medication





4. Educational Strategies to Improve Drug Use in Oman

4.1 Preservice Training

4.1.1 It is easier to teach students good practices than to change the habits of established

practitioners. Therefore it is essential to establish good and appropriate undergraduate training

in pharmacology and therapeutics including the importance of non drug treatment. Part of this

training should be directed towards understanding of the cost implications of their prescribing.









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4.1.2. Tutors in therapeutics and pharmacology in all training health institutions will be made

aware of the importance of teaching Rational Drug Use. (see 2.4).

4.1.3. The curricular of all courses will be reviewed to include lectures on the essential drug

concept, the side effects of drugs, drug interactions, the abuse of antibiotics, rational drug use

and appropriate prescribing and dispensing. Questions on these subjects will be included in

the qualifying examinations.

4.1.4 The “Rational Prescribing Officers” , in cooperation with the tutors of preservice

training, will prepare lecture notes on the above subjects and offer their services to the

training health institutions as guest lecturers. (see 3.1.1). Copies of “A Model Guide to Good

Prescribing” should be made available to the students.

4.2 Inservice Training

4.2.1 A base line review will take place in selected health facilities of the type and nature of

inservice training, at present, provided. This can, if necessary, take place at the same time as

the Prescribing and Dispensing Survey. (see 1.5.)

4.2.2. Senior and respected clinicians in each health facility responsible for training will be

made aware of the importance of rational prescribing.(see 2.5). An each hospital should

appoint one senior doctor to be responsible of inservice education. He will be a member of

the Hospital Drugs and Therapeutic Committee and will report to it.

4.2.3. In general the most effective inservice training is done in small groups or on a face to

face basis. Each hospital drug and therapeutic committee will ascertain the best methods of

promoting rational drug use and improving the prescribing habits of established prescribers in

their health facility.

4.2.4. Regular audit of prescribing and dispensing habits with “feed back” to the prescriber

and dispenser will be an integral part of inservice training. This may be done by the following

methods:

• sitting in during the consultation process or observation of dispensing practices.

• patient registers with a column for treatment as well as diagnosis

• suitably designed duplicate prescription pads (diagnosis to be included)

• analysis of prescriptions issued









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• assessment of the “exit” knowledge of the patient after seeing the prescriber and dispenser

4.2.5 Private practitioner and pharmacists (see 2.7.2) will be invited to attend any inservice

training sessions or workshops that may be arranged by the hospitals or other health

institutions.

4.2.6 The help of outside agencies such as WHO will be periodically to organize training

seminars in specific subjects relating to the rational use of drugs and the appropriate treatment

of specific diseases.









4.3 Drug Company Promotions

4.3.1 Ethical criteria and guidelines will be developed by the DGPA&DC for the conduct of

individuals and companies promoting drugs and for drug company sponsored clinical meetings

following those proposed by WHO (1988). These guidelines will be circulated to companies

operating in Oman.

4.3.2 Periodic monitoring of drug literature and drug promotion will continue by the

DGPA&DC to ensure that these guidelines are being followed.

4.4. Printed Education of Health Providers.

4.4.1. Any relevant information that can be obtained from reputable external sources such as

UNICEF and WHO relating to treatment protocols or the rational use of drugs will be widely

circulated to health facilities.

4.4.2 An Oman Drugs and Therapeutics Newsletter should be considered and it will contain

items relating to treatment, rational and irrational drug use. Information on the relative cost

of drugs with similar therapeutic actions will be included. Ways will be sort to make this

publication as “user friendly” as possible.. This newsletter will be circulated to health

providers by sending it to all hospital pharmacists to distribute.

4.5 Patient Education

4.5.1. A campaign will be mounted to raise to public awareness of the importance of rational

drug treatment. It will be targeted to those issues that appear relevant from the knowledge,

attitudes and practices base line study. This will be done by the concerned department with









10

the support of the Rational Drug Use Team and the DGPA&DC (see 3.1.2). This may

include messages such as:

• the best treatment is often advice from the doctor and not medication.

• if medication is required be sure that you know how to take it.

• complete the course of treatment.

• do not accept medication from unqualified source

• be prepared to report any abnormal side effects from the drugs etc.

• return unused medication to the pharmacy

4.5.3. Health facilities will be required to provide more educational training and literature to

promote preventative health measures that will reduce the need for medication.

4.5.4 The mass media, television, radio and the press will be encouraged by the MOH to be

involved in such a campaign. Health education messages through other sources will be

considered i.e. dramas, the design of postage stamps, simple slogans on commonly used

products etc.

4.5.5 Schools will be targeted to provide education to 14 to 15 year old pupils in the Rational

Use of Drugs.







5. Managerial Strategies to Improve Drug Use in Oman.

5.1 Patient Management Guidelines

5.1.1 The present selection of excellent Patient Management Guidelines produce in Oman will

be expanded to include other diseases. The information in these will form the basis of pre and

inservice teaching on the relevant subject.

5.1.2 The size and nature of these publications do not allow easy reference. They are too big

to be carried in a pocket and the particular treatment protocols are not sufficiently clearly laid

out in step by step manner. However their main recommendations will be included in a clear

and simple manor in the Standard Treatment Guidelines (5.3.)

5.2. Ministry of Health Drug National Formulary

5.2.1 A Ministry of Health Drug National th Formulary is being developed at present and

this process will continue with help from WHO. It will include all the drugs at present on the









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Approved Drug List. As before the drugs will be listed in Chapters, each of which is related to

a particular system of the human body or to an aspect of medical care.

5.2.2 At the beginning of each chapter there will be appropriate notes for the prescriber.

5.2.2. All drugs will be described by their generic name. Any trade names will be in italics.

5.2.3. With each drug there will be clear information regarding:-

• indications

• dosage

• suggested length of treatment

• contra-indications and side effects

• cost (ABC listing)

• medical importance (VEN listing)

5.2.4. The main indications and side effects will be highlighted

5.2.5. Included in the formulary will be guidance on prescribing, specifically:

• the correct way to write a prescription

• prescribing for children, the elderly and in pregnancy

• controlled drugs and drug dependence

• adverse reaction to drugs

• prescribing in palliative care

• the treatment of drug overdose and poisoning

5.2.6. The formulae will be of such a size that it fits easily into a coat pocket.

5.3. Standard Treatment Guidelines

5.3.1. Standard Treatment Guidelines for Oman will be developed. The WHO/DAP/94.14

publication “Producing National Drug and Therapeutic Information” suggests ways in which

this can be done.

5.3.2. The guidelines will give definitive advice on the recommended (1st line) treatment for

the most common conditions occurring in Oman. Alternative treatment (2nd line) will also be

suggested if the first line treatment is not appropriate for the patient.

5.3.3 The need for this manual is evident by the widely differing treatments apparently

offered at present. Providing standard treatment guidelines are followed they will:









12

• offer more consistency to patient with an improved quality of care

• be a basis of monitoring of prescribing habits

• make treatment for a condition standard so that the physician can

concentrate on reaching the correct diagnosis.

• make drug demand more predictable and allow prepacks

5.3.4 The manual will be prepared by the DGHA in collaberation with the DGPA&DC,

advice wil be sort from experts .

5.3.5 Draft copies of the manual will be circulated and approved by the CDC. It will also be

pocket size (see 5.2.7.)

5.3.6 Once final copies have been printed of both the STGs and the Ministry of Health

Formulary a series of workshops or seminars will be arranged to introduce them to the

prescribing and dispensing health professionals in each region.

5.4 Course of Treatment Packaging and Labeling

5.4.1. Consideration will be given to standardized courses of treatment that may be prepacked

and labeled in the pharmacy ,It has the advantage of-

• saving the pharmacy staff time

• clearer instructions for the patient

• educating the doctor to prescribe a standard course of treatment

5.4.2. The pharmacy staff will query any prescriptions that vary from these amounts.

5.4.3. Thought will be given to improving the labeling and the instructions on the label and in

the package. There is no place, at present, for the patients name on the label or any

precautions to be observed when taking the medication. Instructions in the packet may be in a

language that is not understood by the patient.

5.4.4 It is recommended changing the packaging to plastic bottles or containers. These may be

already labeled with this required information and provide more protection to the drugs.

5.5 Prescription Forms

5.5.1 Further thought will be given the format of the prescription form with a possible

inclusion of space on it for the diagnoses. ( as a code number). This will enable the pharmacist









13

and others to check the appropriateness of the prescription and whether it conforms with the

standard treatment guidelines.

5.5.2 A system for allowing repeat prescriptions should be standardized. This will permit the

patient with a stable chronic condition to be able to collect their controlled medication at a

peripheral health centre monthly and attend the specialist in the central hospital at less

frequent intervals e.g. 3 to 6 monthly.





5.6 Reporting of Adverse Drug Reactions

5.6.1 Adverse drug reactions must be reported to the Hospital Drugs and Therapeutics

Committee to be investigated and analysed by them. Their finding should be transmitted to

the Drug Imformation Centre in the DGPA&DC.





6. Regulatory Strategies

6.1 MOH approved drug list

6.1.1 This list is an excellent tool to limit excessive prescribing and it will be keep constantly

under review. In particular the level of use of the expensive drugs will be considered.

6.1.2 The present booklet listing these drugs will be replaced by a Minstry of Health

Formulary once it is available. (see 5.2).

6.2 Prescription Controls

6.2.1. Level of use restriction and automatic stop orders are already in place and will be

constantly reviewed. (5.5.2).

6.2.2. Ways will be sought to put a limit of the amount of a drug that can be prescribed. This

particularly applies to drugs used for common short term conditions. Permission would have

be sort to prescribe larger amounts.

6.2.3. The practice of “corridor prescribing” will continue to be discouraged. Prescribers

should not be allowed to prescribe outside the clinical situation unless the circumstances are

exceptional. In particular indiscriminate prescribing to friends and relatives and the

substitution of a private prescription by a public prescription will be prohibited.









14

6.2.4. When adequate staff are available checks will be made to match the prescription with

the entry in the patients' records so that “adding items” by the doctor or even the patient can

be limited.

6.3. Prescription Charges

6.3.1 Introducing any charges into a “free “ system is seen to be politically unattractive but in

the face of escalating costs and a diminishing budget it is the only way to curb expenditure

and abuse of the system. This has proved to be true all over the world and has found to be so

in Oman. A small charge for medication will not cause major hardship and will limit the

casual and sometime irrational prescribing. Cost sharing has generally had the effect of

making patients value the service provided and the MOH is introducing a prescription charge.

6.4 Clinical Attendance Cards

6.4.1 The present card system which identifies the patient’s hospital number and his/her

records is clearly not working because

• patient get separate cards for each department in the hospital.

• patients may replace “lost” cards for a nominal charge with the result that

he/she may have many record files. This allows “doctor shopping” and

reduces continuity of care.

• there are health centres operating without a card system especially in the

afternoons.

6.4.2 Consideration will be given to tightening up the present card system. This may be done

in any of the following ways:-

• a substantial charge made to replace a card

• the design of the card reviewed so that it can be more attractive. (Plastic

folder etc) This will have the effect of making the patient value the card like

a passport.

• substitution with a family card system restricting the patient to only attend

the clinic in his/her area. (There has to be a system for providing emergency

treatment when away from this area).

• an attendance charge for each visit.









15

These measures may reduce the patient load on the services and allow more time for the

prescribers and dispensers.

6.5 Generic Names

6.5.1 Where possible drugs procured will have the generic name and not a proprietary name

on the label.

6.5.2 Doctors and pharmacists will continue to be reminded to use generic names.







Conclusion.

The success of a Rational Drug Use policy depends on measuring existing practices,

identifying drug use problems and their causes, designing and implementing interventions and

finally measuring the resulting outcome.

Some interventions can be expensive failures. It is therefore important to choose those which

are likely to have the most cost effective impact. This document has endeavored to do that.

Some aspects of it will clearly take time to develop, others can be put into place almost

immediately. The enclosed GATT Chart gives a time scale for these operations and a rough

estimate of their cost. The overall saving that this policy will provide is more difficult to

quantify but it will undoubtedly improve patient care.

The Policy Document has been produced by the Directorate General of Pharmaceutical

Affairs and Drug Control with help from the Drug Action Program of the World Health

Organization. It incorporates recommendations made by the participants of a Seminar on

Pharmaceutical Care held in Muscat on 8th - 10th December 1997.









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